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Pediatric Brain TumorNCT07094360

Effect of Hydrotherapy on Children With Brain Tumor

A study testing Land-based exercise program and Hydrotherapy besides Land-based exercise program in people with Pediatric Brain Tumor, run by Cairo University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Brain and spinal cord tumors are the second most common cancers in children (after leukemia). They account for about 1 out of 4 childhood cancers. More than 4,000 central nervous system tumors are diagnosed each year in children and teens. (Blaney et al., 2011). Read more about this study

Who is it for?
Ages 5 to 14 years
Conditions the study is for
Pediatric Brain Tumor
What is being tested?
Land-based exercise program and Hydrotherapy besides Land-based exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Nov 2016to Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • They will be selected according to the following criteria:
  • Children between 5-14 years old.
  • Children after brain tumor resection surgery 4 weeks post-surgery.

Who cannot join

  • Children who have one or more of the following criteria will be excluded from the study:
  • Children who cannot follow orders or instructions.
  • Children with a genetic disorder.
  • Children with a chronic lung disease.
  • Sever cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest).
  • Children with a neuromuscular disease.

About this study

Official title: Effect of Hydrotherapy on Performance in Children With Brain Tumor

  • Background: Brain and spinal cord tumors are the second most common cancers in children (after leukemia). They account for about 1 out of 4 childhood cancers. More than 4,000 central nervous system tumors are diagnosed each year in children and teens. (Blaney et al., 2011).
  • Aim: It has been reported that those children have easy fatigability so the purpose of this study is to investigate the effectiveness of hydrotherapy on endurance in these Children.
  • Significance: The effects of physical exercise training interventions for childhood cancer participants are not yet convincing due to small numbers of participants and insufficient study methodology. More and high-quality evidence is needed in order to be able to draft exercise and physical activity guidelines for this population. Despite the positive results of exercise interventions in adult cancer patients, the evidence for benefits in childhood cancer patients is limited (Braam et al., 2013).

An 8-week deep water exercise program was clinically effective for improving CRF(Cancer-Related-Fatigue), muscle strength, and several aspects of mood state as compared with usual treatment care at short and medium term in breast cancer survivors reporting a moderate rate of fatigue (Irene et al., 2013).

Read more

In this study, the investigators are trying to find out the effect of hydrotherapy as a way of fun and amusement that children can do easily with great pleasure and also as a treatment method.

  • Subjects: Thirty children of both sexes will participate in this study. Inclusion criteria: Children between 5-14 years old after brain tumor resection surgery 2 weeks post-surgery. Exclusion Criteria: Cognitive or mental (developmental), or both, impairment, Children with a genetic disorder, Children with a chronic lung disease, Severe cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest), Children with a neuromuscular disease.
  • Methodology:

For Evaluation: Lafayette manual muscle tester to assess muscle endurance/strength (Lafayette instrument evaluation, 2015). The pediatric quality of life inventory version 4(PedsQL) is used to assess quality of life (Varni et al., 1999). The nine-minute run-walk test (Guedes et al., 2006) and the timed up-and-down stairs test (Zaino et al., 2004) are to measure Cardiorespiratory fitness.

For Treatment: Children will be divided into two groups, control group will receive a land-exercise program and study group will receive the same exercise program then repetition of these exercises under water to study the effectiveness of using hydrotherapy. The program will take 30 minutes (5 minutes each with 1 minute rest in between).

The selected program will be in the form of:

  1. Sitting while strengthening shoulder horizontal adductors by using weights.
  2. Sitting while pushing down by using weights.
  3. Sitting while strengthening elbow extensors by using weights.
  4. Sitting while holding weights for a while.
  5. Standing on uneven surface.
  6. Pushing downs by legs.
  7. Sitting balance.
  8. Sitting with pushing by hands while making legs as glue.
  9. Sitting with kicking by legs while fixing hands.
  10. Standing and throwing a ball.
  11. Weight shifting and recovery while initiating single limb support.
Being tested
Land-based exercise program, Hydrotherapy besides Land-based exercise program
Keywords
Hydrotherapy, Performance, Children, Brain tumor
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Land-based exercise programOther

    Land-based exercise program

  • Hydrotherapy besides Land-based exercise programOther

    Hydrotherapy besides Land-based exercise program

Study groups in NCT07094360
Study groupRoleWhat they receive
Land-based exercise programExperimentalLand-based exercise program
Receives: Other: Land-based exercise program
Hydrotherapy besides Land-based exercise programExperimentalHydrotherapy besides Land-based exercise program
Receives: Other: Hydrotherapy besides Land-based exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle strength of upper and lower limb muscles

    Lafayette Manual Muscle Tester:

    The test was performed by applying force to the limb of a child as he/she resists the force isometrically. The objective of the test is for the clinician to overcome or "break" the child's resistance. When the resistance "break" occurs the Lafayette Manual Muscle Tester (MMT) records the peak force and the time required to achieve the "break providing reliable, accurate, and stable muscle strength readings that conform to most manual muscle testing protocols. The MMT also features a wide range of customizable options for data storage, preset test times, and force thresholds

    Measured: 4-6 months

Secondary outcomes (2)
  1. Pediatric quality of life

    The pediatric quality of life inventory version 4 (PedsQL) is a modular approach to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Pads Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. The PedsQL Brain tumor module was used in this study.

    Measured: 4-6 months

  2. Cardiorespiratory fitness

    The Six-minute run-walk test:

    This test has been used as an adaptation of the 12-minute Cooper test for children under the age of 12, and is also used in Brazil and internationally as an alternative to motor test batteries for CRF assessment (Gaya et al., 2007). Currently, it becomes modified to the 6-minute walk

    Measured: 4-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study startNov 2016
  3. Primary completionDec 2016
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07094360
Sponsor's protocol ID
2490-2016
Status last verified
Jul 2025
First submitted
21 Jul 2025
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Land-based exercise program and Hydrotherapy besides Land-based exercise program in people with Pediatric Brain Tumor, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle strength of upper and lower limb muscles (time frame: 4-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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